A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

Parkinson's Disease (Disorder) Clinical Trial

Official title: A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

Status Completed

Clinical Trial Summary

To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.

Clinical Trial Description

This was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study consisted of a 3-week, open-label IR CD-LD dose adjustment period; a 4-week, open-label period for conversion to IPX203; followed by a 13-week double-blind treatment period with participants randomized in a 1:1 ratio, stratified by center, to receive either IPX203 (with matching IR CD-LD placebo) or IR CD-LD (with matching IPX203 placebo). ;

Related Conditions & MeSH terms

• Disease
• Parkinson Disease
• Parkinson's Disease (Disorder)

• NCT number: NCT03670953
• Study type: Interventional
• Source: Impax Laboratories, LLC
• Status: Completed
• Phase: Phase 3
• Start date: November 6, 2018
• Completion date: June 15, 2021